EnCompass is a modular automation solution for MDR/IVDR content compliance that delivers 50% cost and turnaround savings. Each component can be employed individually or together, based on specific client requirements. The full system includes:
Supports increased content volume and velocity due to MDR/IVDR requirements. “We process ten times more content with the same headcount thanks to XML technology from TransPerfect” – Medtronic
Including AI-AssistTM translation automation and business intelligence reporting. Supports increased translation volumes due to MDR/IVDR requirements.
Supports direct-to-user labeling and publication and master data management , helps satisfy EU UDI requirements.
The EnCompass UDI scanning app ensures your product is correctly labeled and registered in FDA's GUDID as well as manufacturers' PLM systems. Our tested approach helped one manufacturer solve a $3 billion inventory management and regulatory compliance issue and saved tens of millions of software costs in the process.